Sempermed Glove Glossary Lite

Acceptable Quality Level (AQL) - A destructive test methodology applied to a defined, partial quantity from the total manufactured products, of which an assessment of the entire production can be made.

Chloroprene - A colorless liquid organic compound used in the synthesis of neoprene and certain other rubbers. The structure of the chloroprene molecule is very similar to that of isoprene; the molecule contains two double bonds and is readily polymerized, abbreviated as "CR".

Co-Polymer - A compound made by polymerizing two or more dissimilar monomers

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Hypoallergenic - As a term for gloves, the claim hypoallergenic was developed to describe a reduced potential for developing a dermatological response to chemicals utilized in production of a given product. The 200-person Modified Draize test is used to determine potential irritancy or allergic contact dermatitis (Type IV) to the product. After producing product to meet these requirements, manufacturers were allowed to utilize the term hypoallergenic as an identifier for the product (a claim). However, in recent years individuals have also developed Type I allergic reactions in association with the proteins in gloves. Because the label claim of hypoallergenic was being interpreted to refer to both Type IV (chemicals) and Type I (protein) allergies, rather than just Type IV, this claim was removed from all gloves September 30, 1998.

Industrial gloves - Any non-medical, general purpose glove meeting specific environmental and use requirements as prescribed by ISO, ASTM, CE, EN, FDA, or other standards or regulating bodies. Industrial gloves are ranked by use (general purpose, cleanroom, food, etc.) and/or risk (minor, intermediate, or complex).

Latex -  Commonly, it is a milky, usually whitish fluid obtained from over 1,000 species of trees and plants. Relating to gloves, it is natural rubber latex, the raw material from the Hevea brasiliensis tree. It contains isoprene, the "rubbery" component of latex products. The latex liquid also contains the proteins (allergens) to which latex allergic (Type I) individuals react.

Low Protein - The amount of protein on a glove generally correlates with the amount of allergen (the proteins people react to). However, not all latex proteins are allergens.  The Lowry Protein Assay is a test method used to determine the concentration of total protein present in a sample. A Modified Lowry assay was developed for use with latex products. In the Modified Lowry assay (ASTM D5712), latex proteins are extracted from products and purified by acid precipitation. This step diminishes the chemicals present in the product that may interfere with the assay. A protein detection agent is then added that increases in color intensity with increasing amounts of protein. Results are expressed as micrograms (_g) of total protein extracted or microgram per gram (_g/g) of sample. The greater the number, the greater the amount of protein present. This is the only method currently accepted by the government for the measure of protein level in latex products.

Modulus - A measurement of the resistance to stretch. A lower modulus represents a glove in which it is easier to move and thus less fatiguing.

Neoprene - A synthetic rubber developed as an oil-resistant substitute for natural rubber latex. It also resists a broad range of chemicals.

Nitrile- A synthetic polymer exhibiting rubber-like characteristics when vulcanized. Primary material is Acrylonitrile Butadiene, hence the name "nitrile."

Non-Latex - Containing no natural rubber latex (e.g. nitrile, vinyl, neoprene, etc.).

Non-Sterile - a clean, but not sterilized product suitable for examination but not sterile procedures.

Palm Width - Dimensional measurement. For gloves usually measured across the palm, from just above the thumb to just below the small finger.

Pinholes - Minute holes that may be present in glove film. They are often created by the presence of debris (dust, dirt, etc.) during the manufacturing process.

Powder - Donning powder on gloves is composed of cornstarch (USP absorbable dusting powder). Some companies have qualified a lactose starch. Powder facilitates donning and absorbs sweat. Studies have shown powder to function as abrasive particles, immunological activators, and possibly as vehicles for the dissemination of chemicals, proteins and microorganisms. Powder has been implicated in lowering of resistance to infection. It also has been shown to interfere with wound healing processes, increasing the risk for incremental complications in OR and postoperative care.

Powder Free - the absence of powder in the glove.

Sempermed -  A Delaware Corporation established in May 1998. With roots dating back 175 years, Sempermed USA enjoys a long heritage of manufacturing excellence. Sempermed USA offers a full line of quality medical and industrial gloves made from latex, nitrile, vinyl, and chloroprene. Sempermed USA also maintains a dedicated sales team that provides education, sales, and technical support to both the distributor and end user. In addition to corporate headquarters in Palm Harbor Florida, Sempermed's regionalized distribution and warehousing facilities are located in New Jersey, Florida and California, providing coast-to-coast coverage and reduced order lead times.

Sterile -  Assurance that a given device is without living organisms. The sterility assurance level (SAL) accepted by the United States (Association for the Advancement of Medical Instrumentation -- AAMI) is generally 10-6 (a probability of one non-sterile unit per million tested); sterile gloves are needed for certain medical procedures, such as surgery, wound dressing change, catheterization, etc.

Vinyl - Usually refers to polyvinyl chloride (PVC). Resin used as a rubber substitute in many medical and industrial applications. Although the material itself is a barrier to microorganisms, its non-elastic properties do not allow for maintenance of barrier integrity after extended use, or in rigorous procedures.

Water Leak Test - A test procedure recognized under ASTM D5151 and FDA protocols to determine the AQL level of an exam glove. The latex glove is filled with a prescribed amount of water (1000ml) and must remain completely leak-proof over a defined period of time.  All factories that manufacturer Sempermed gloves routinely conduct this test for each production lot.